Altamonte Springs, FLNCT07325292Now EnrollingIRB Ready

Multiple Sclerosis Clinical Trial in Altamonte Springs, FL

Access cutting-edge multiple sclerosis treatment through this clinical trial at a research site in Altamonte Springs. Study-provided care at no cost to qualified participants.

Sponsored by Sanofi

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Expert Care in Altamonte Springs

Access multiple sclerosis specialists at no cost

IRB Approved

This study follows strict safety protocols and ethical guidelines

No-Cost Care

All study-related multiple sclerosis treatment provided free

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Check if you qualify for this multiple sclerosis clinical trial in Altamonte Springs, FL

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Your information is protected and will only be shared with the research team.

Why Participate?

  • No-Cost Study Care

  • Local to Altamonte Springs

    Convenient for FL residents

  • Cutting-Edge Treatment

    Access to innovative therapies

  • Expert Medical Care

    Close monitoring by specialists

  • Possible Compensation*

    For time and travel

*Compensation varies by study. Confirm details with coordinator.

Simple Process

  1. 1Submit this form
  2. 2Phone screening
  3. 3Visit Altamonte Springs site if eligible
  4. 4Begin participation

About This Multiple Sclerosis Study in Altamonte Springs

This is a randomized, open-label, parallel, Phase 3 study with 2-arms for treatment. The purpose of this study is to evaluate SC administration of frexalimab every 4 weeks (q4w) compared to IV administration of frexalimab q4w in male and female participants with RMS and nrSPMS (aged 18 to 60 years at the time of enrollment). People diagnosed with MS are eligible for enrollment as long as they meet all the inclusion criteria and none of the exclusion criteria. Study details include: The study intervention duration will be 48 weeks (12 months) for Parts A and B combined. Optional Part C will last until the initiation of a long term safety study for Frexalimab.The follow up duration after the end of study intervention (in case of discontinuation) will be 6 months. The number of scheduled visits (Parts A and B) will be 17 or 11 for participants receiving frexalimab SC or IV, respectively, with an on-site visit frequency of every month between Week 4 and Week 24 in Part A, then every 1 to 3 months in Part B, then every 6 months in Part C. Participants discontinuing treatment before the End of Study will have an additional 3 follow-up visits.

Sponsor: Sanofi

Who Can Participate

Inclusion Criteria

The participant must qualify for inclusion per either Group A or B criteria as detailed below, meeting all the inclusion criteria of the applicable group: Group A (RMS)
The participant must be 18 to 55 years of age, inclusive, at the time of signing the informed consent.
The participant must have been diagnosed with RMS in accordance with the 2017 revised McDonald criteria.
The participant must have an Expanded Disability Status Scale (EDSS) score of ≤5.5 at the first visit (Screening Visit).
The participant must have at least 1 of the following prior to screening:
1 documented relapse within the previous year OR
2 documented relapses within the previous 2 years, OR
1 documented Gd enhancing lesion on an MRI scan within the previous year. Group B (nrSPMS)
Participant must have a previous diagnosis of RRMS in accordance with the 2017 revised McDonald criteria
The participant must be 18 to 60 years of age, inclusive, at the time of signing the informed consent.
The participant must have a current diagnosis of SPMS in accordance with the clinical course criteria revised in 2013.
The participant must have documented evidence of disability progression observed during the 12 months before screening.
The participant must have an absence of clinical relapses for at least 24 months.
The participant must have an EDSS score between 3.0 and 6.5 points, inclusive, at the first visit (Screening Visit). Participants from Group A and Group B are eligible to be included in the study only if all of the following criteria also apply: \- Contraceptive use by men and women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.

Exclusion Criteria

The participant has been diagnosed with primary progressive MS according to the 2017 revision of the McDonald diagnostic criteria.
The participant has a history of infection or may be at risk for infection:
Fever within 28 days of the Screening Visit
Presence of psychiatric disturbance or substance abuse
History, clinical evidence, suspicion or significant risk for thromboembolic events, as well as myocardial infarction, stroke, and/or antiphospholipid syndrome and any participants requiring antithrombotic treatment.
Current hypogammaglobulinemia defined by Ig levels (IgG and/or IgM) below the LLN at screening or a history of primary hypogammaglobulinemia.
A history or presence of disease that can mimic MS symptoms.
The participant has a contraindication for MRI. The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in Altamonte Springs?

Yes, this clinical trial (NCT07325292) has an active research site in Altamonte Springs, FL that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

Multiple Sclerosis Treatment Options in Altamonte Springs, FL

If you're searching for multiple sclerosis treatment options in Altamonte Springs, FL, this clinical trial (NCT07325292) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our Altamonte Springs research site is actively enrolling participants for this clinical trial. You'll receive care from experienced multiple sclerosis specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all multiple sclerosis clinical trials near you to find additional studies recruiting in your area.

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